Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)

Myelodysplastic Syndromes Clinical Trial

— QPL-MDS  

Official title:

Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02781441
• Other study ID #: QPL-MDS-IPC 2014-013
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2016
• Last updated: September 1, 2017
• Start date: April 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2017
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: 0033491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MDS are a diverse group of hematopoietic malignancies, which mainly occur in patients over 75 years of age. Incidence rate in 2012 in France was more than 6 cases per 100 000 person-years. MDS are characterized by ineffective haematopoiesis causing cytopenia, and by leukemic transformation. The disease is heterogeneous, its pathophysiology complex and clinical evolution variable.The few data available on MDS patients show how difficult it is to understand MDS, its prognosis and the reasons for prescribing or not some treatments. In the context of a highly complex potentially lethal disease such as MDS, it is of utmost importance to optimize the information conveyed to patients. Particularly, 70.5% of MDS patients surveyed in our developmental study would have preferred more information about prognosis at diagnosis disclosure.

A simple intervention based on the use of a question prompt list (QPL), would greatly improve the information process by helping patients to express their main concerns at their medical consultations. Cultural differences may exist in the appraisal of QPLs and QPLs have not yet been widely used in France.

However, in line with the previous results available in the literature and in a context a priori favourable to the use of such an instrument, the investigators hypothesise that use of a QPL will increase MDS patients' expressions of concerns and questions at their medical consultations. Particularly the investigators assume that the discussion about prognosis will be facilitated, without increasing anxiety because patients remain free to ask or not for such information. The use of QPLs would also be a way to limit social inequalities related to insufficient information and to encourage patient-doctor communication and meeting of patient preferences which could lead to better health outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients newly referred for a MDS in one of the participating centres

• Older than 18

• Able to answer a self-administered questionnaire

• Having signed an informed consent

• affiliated to the French Social Security System

Exclusion Criteria:

• emergency,patients deprived of liberty or placed under the authority of a tutor

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Behavioral:
• Question prompt list (QPL)

• Education brochure of Groupe Français des Myélodysplasies

Locations

Country	Name	City	State
France	Chu Grenoble	Grenoble
France	Institut Paoli-Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients having discussed as they wished about the prognosis of their MDS in the next medical consultation	The discussion about prognosis will be collected through the audiotaping of the consultation.	17 months
Secondary	number of questions and concerns expressed in each content category covered by the QPL (including prognosis)	Data collected through the audiotaping of the consultation	17 months
Secondary	Duration of the recorded consultation	Data collected through the audiotaping of the consultation	17 months
Secondary	Quality of life	Questionnaire	17 months
Secondary	Anxiety	Questionnaire	17 months
Secondary	Satisfaction with the provided information	Questionnaire	17 months